On track to deliver important clinical data in 2016
Guildford, UK - 16th December 2015: Ergomed plc, (LSE: ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, provides an update on its current co-development partnerships. Ergomed’s four active partnerships have studies in late stage development with the potential to deliver significant Phase II and Phase III news flow with two studies scheduled to report results in 2016.
Ergomed’s growing portfolio of drug development partners range from single product university spinouts and US-listed biotech companies to mid-sized Pharma companies developing products in oncology, neurology and rare diseases. Under these agreements Ergomed is contributing to the total cost of the clinical trials and in return will receive a share of any proceeds generated from the commercialisation of the partnered drug asset. Ergomed is committed to building its portfolio of co-development assets and delivering significant clinical data and is targeting further partnerships in 2016 with the potential to create significant shareholder value in the next few years.
CEL-SCI (NYSE MKT: CVM): Ergomed and CEL-SCI are running one of the largest Phase III studies in head and neck cancer with the product Multikine. With more than 80 sites open and more than 600 patients enrolled out of a target of 880 the study is now in an advanced stage. This novel treatment aims to treat advanced primary head and neck cancer and if successful will be a significant advance in the treatment options available to patients. Ergomed and CEL-SCI are also collaborating on a Phase I study in peri-anal warts in HIV/HPV co-infected patients.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ): The ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with Zoptrex™ (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, is proceeding well. In June 2015, Ergomed reached the recruitment target of 500 patients ahead of schedule and in October 2015 the Data and Safety Monitoring Board recommended the continuation of the ZoptEC Phase III Trial in Advanced Endometrial Cancer. The ZoptEC study is being run in 115 centers from North America, Europe, Israel and other countries under a Special Protocol. Final results from the study are expected in 2016.
Ferrer: Ferrer is a privately-held Spanish pharmaceutical company. In 2014, together with Ildong Pharmaceuticals, Ergomed joined forces to develop Ferrer’s novel treatment for insomnia, Lorediplon. Recruitment in this 130 patient, Phase IIa study began as planned in July 2015 and is scheduled to complete by late 2016. To date more than 45 patients have been randomised. Lorediplon has demonstrated a potent hypnotic profile and extended systemic half-life in preclinical and clinical studies, properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. The Phase IIa study is being run at specialist sleep centres and aims to confirm the promising Phase I results and hopes to promote a longer duration of sleep throughout the night in patients with insomnia. Final results from the study are expected in 2016.
Dilaforette: Ergomed’s recent co-development partnership with Dilaforette is our first targeting an orphan drug indication. The partnership is exploring the potential of sevuparin as a novel treatment for Vaso-Occlusive Crisis (VOCs) in patients with sickle-cell disease (SCD). In October 2015, the companies announced the start of recruitment into a multi-centre, international, randomised Phase II study performed in Europe and the Middle East. Ergomed’s MENA infrastructure is well positioned to access patients in the Middle East, where SCD is a significant healthcare problem. In addition, Ergomed’s site management model supports the identification and management of SCD patients when they suffer a VOC and are in need of hospitalisation. Results from this Phase II trial with sevuparin are expected in the second half of 2016.
Ergomed is investing a proportion of its revenues from conducting this Phase II trial with sevuparin in return for an equity stake in Dilaforette. Dilaforette is a private Swedish biotech company and is part of the Karolinska Development AB (STO: KDEV) portfolio. Sevuparin was developed based on research from the Karolinska Institute and Uppsala University.
Synta Pharmaceuticals (NASDAQ:SNTA): Announced this year the early termination of its Phase III study of Ganetespib for advanced non-small cell lung cancer (NSCLC). Ganetespib has a number of trials ongoing under investigator sponsored studies and Synta will evaluate next steps after these report results. Ergomed’s carried interest remains in place but no further investment by Ergomed is planned.
Miroslav Reljanovic, CEO of Ergomed plc, commented: “Our growing pipeline of co-development partnerships is on track and we are looking forward to providing updates on two late stage clinical data readouts in 2016. As we continue to see opportunities in this sector and as the portfolio expands we will be in a strong position to place more emphasis on this division of our business.
“We believe that our hybrid model of a profitable, healthcare services business combined with managed investment in an exciting co-development portfolio has the potential to deliver significant value for investors while balancing the risks over the next few years.”
